The investigators noted that these data provide robust and promising evidence that eptinezumab is associated with a rapid preventive effect in chronic migraine that is sustained for 3 months after a single infusion.

By: Matt Hoffman

Published: July 26, 2019

David W. Dodick, MD

Results of a randomized phase 2b clinical trial suggest that eptinezumab is both effective and well-tolerated in the preventive treatment of chronic migraine, and according to the investigators, justifies the phase 3 clinical trials in its development for migraine prevention.

In a cohort of 495 treated patients, the ≥75% responder rates to the intravenous anti-calcitonin gene-related peptide (CGRP) monoclonal antibody was an average of 29.9% across the 4 doses measured in the trial—300, 100, 30, and 10 mg. Led by David W. Dodick, MD, professor of neurology, Mayo Clinic College of Medicine, the investigators noted that the results for the 3 highest doses (mean ≥75% responder rate, 30.9%) was statistically favorable compared to placebo for the key secondary end points.

“These results provide preliminary, yet robust and promising evidence that eptinezumab administered by IV infusion to patients with [chronic migraine] is associated with a rapid migraine preventive effect that is sustained for 3 months after a single dose and is associated with acceptable safety and favorable tolerability profiles,” Dodick and colleagues wrote.

In total, 616 patients with chronic migraine were enrolled, with a mean onset at ≤35 years and a history of the condition for ≥1 year. They were randomized 1:1:1:1:1 to a single infusion of 300- (n = 121), 100- (n = 122), 30- (n = 122), or 10-mg (n = 130) eptinezumab, or placebo (n = 121). The treatment period was 12 weeks, and the screening period was 28 days, during which patients must have had ≥15 headache days, including ≥8 migraine days, with ≥5 migraine attacks.

“[This] analysis suggests that a clinically meaningful reduction of migraine activity can be achieved as early as day 1 post-infusion,” Dodick et al. detailed, noting that the percentages of patients who had migraine 1 day post-infusion for the 300- and 100-mg groups were 26.3% and 29.3%, respectively, compared to 48.7% for placebo. On average, 59.1% of those in the 300-mg group, 60.4% of those in the 100-mg group, and 58.7% of those in the placebo group experienced a migraine on any given day during the 28-day baseline period.

“This represents, for the eptinezumab groups, a > 50% reduction in the likelihood of a migraine day in the 24 hours post-infusion compared with baseline,” the investigators wrote.